Kind and Duration of Possible Changes of the Sensory Profiles After the Topical Application of Capsaicin (8%) in Patients With Peripheral Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds
研究概览
简要总结
The treatment of neuropathic pain ist still a challenge. A new promising therapy is the use of capsaicin on skin.
The investigators first experiences with capsaicin in patients with peripheral nerve injury showed changes in the sensibility, which achieved its maximal extent after four weeks and was regressive, but not completely abolished 1,5 months after application.
In this study the investigators hope to specify, how long and in which way exactly this changes in sensibility appear.
详细描述
The topical application of a high dosage of capsaicin (8%) is a new promising approach. There is only little knowledge about the extent and the duration of drug-induced changes of detection and pain thresholds based on a currently recommended standardized quantitative sensory testing (QST). The assessment of QST changes would be an important step forward to understand the way of action as well as the time course of the presumed recovering of the C-fiber function after topical application of a high concentration capsaicin patch.
10 patients suffering from peripheral neuropathic pain due to peripheral nerve injury and 10 patients suffering from postherpetic neuralgia will be investigated by QST following the protocol of DFNS (German Research Network on Neuropathic Pain), using both thermal and mechanical nociceptive as well as non-nociceptive stimuli.
QST will be performed at the following times:
- at baseline
- 2, 4, 6, 8 weeks later, and every two weeks at least until re-occurrence of pain and/or recovering of the capsaicin-induced worsening of the C-fiber function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years with signed informed consent
- •with planned topical application of capsaicin (8%) and with no involvement in any other study
- •with neurological proved peripheral neuropathy (e.g. peripheral nerve lesion, postherpetic neuralgia) and with remaining moderate pain intensity under the current treatment (> NRS 3; numeric rating scale 0-10)
- •some remaining sensory function at the baseline QST with z-scores ≥ - 3 for cold, warmth and tactile thresholds
排除标准
- •with missing informed consent
- •with any contraindications for capsaicin application
- •with diabetes mellitus,
- •using lidocaine patch in the test area in the last 6 months before enrollment
- •with inadequate knowledge of the german language
结局指标
主要结局
Duration of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds
时间窗: 8 weeks after capsaicin-patch (8%) application
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)
Extent of the functional loss of the C- and A-delta-fibres after therapeutic application of capsaicin 8% as measured by the impairment of the thermal thresholds
时间窗: 8 weeks after capsaicin-patch (8%) application
measurement of thermal detection thresholds for warmth (WDT) and cold (CDT) by QST (standard DFNS protocol), change of z-values for WDT and CDT from baseline to 8 weeks after capsaicin-application (ANOVA)
次要结局
- Decrease of thermal Hyperalgesia(8 weeks after capsaicin-patch (8%) application)
- Decrease of mechanical hyperalgesia(8 weeks after capsaicin-patch (8%) application)
- Decrease of dynamical mechanical allodynia(8 weeks after capsaicin-patch (8%) application)
- Correlation of efficacy on the sensory function and the reported soothing of symptoms after capsaicin-application(8 weeks after application of capsaicin-patch (8%))
研究者
Christoph Maier, Prof. Dr.
Head of the Dep. of Pain Management
Ruhr University of Bochum